Esbriet 267 mg hard capsulesPatient’s LeafletSummary for the - United Kingdom[英国药品]

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Esbriet 267 mg hard capsulesPatient’s LeafletSummary for the

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For doctors

What is it and how is it used?

Esbriet contains the active substance pirfenidone and it is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.

IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply. This makes it hard for your lungs to work properly. Esbriet helps to reduce scarring and swelling in the lungs, and helps you breathe better.

What do you have to consider before using it?

Do not take Esbriet
- if you are allergic (hypersensitive) to the active substance pirfenidone or any of the other ingredients in this medicine (for the full list of ingredients see section 6: Further information) - if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD))
- if you have severe or end stage liver disease
- if you have severe or end stage kidney disease requiring dialysis.

If any of the above affects you, do not take Esbriet. If you are unsure ask your doctor or pharmacist.

Take special care with Esbriet
- You may become moresensitive to sunlight (photosensitivity reaction) when taking Esbriet. Avoid the sun (including sunlamps) whilst taking Esbriet. Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects). - You should not take other medicines, suchas tetracycline antibiotics (such as doxycycline), which may make you more sensitive to sunlight.
- You should tell your doctor if you suffer from mild to moderate liver problems. - You should stop smoking before and during treatment with Esbriet. Cigarette smoking can reduce the effect of Esbriet.
- Esbriet may cause dizziness and tiredness. Be careful if you have to take part in activities where you have to be alert and co-ordinated.
- Esbriet can cause weight loss. Your doctor will monitor your weight whilst you are taking this medicine.

You will need a blood test before you start taking Esbriet and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly. It is important that you have these regular blood tests for as long as you are taking Esbriet.

Children and adolescents
Do not give Esbriet to children and adolescents under the age of 18.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is especially important if you are taking the following medicines, as they may change the effect of Esbriet.

Medicines that may increase side effects of Esbriet:
- ciprofloxacin (a type of antibiotic)
- amiodarone (used to treat some types of heart disease)
- propafenone (used to treat some types of heart disease).

Medicines that may reduce how well Esbriet works:
- omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
- rifampicin (a type of antibiotic).

Ask your doctor or pharmacist for advice before taking any medicine.

Taking Esbriet with food and drink
Take this medicine during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness (see section 4: Possible side effects).

Do not drink grapefruit juice whilst taking this medicine. Grapefruit may prevent Esbriet from working properly.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, planning to become pregnant or think you might be pregnant. The risk to the unborn child is unknown.

If you are breastfeeding, speak to your doctor or pharmacist before taking Esbriet. It is not known if Esbriet passes into breast milk. If you are breastfeeding and you need to take Esbriet, your doctor will discuss the risks and benefits of taking this medicine while breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines if you feel dizzy or tired after taking Esbriet.

How is it used?

Always take Esbriet exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your medicine will usually be given to you in increasing doses as follows:
- for the first 7 days take 1 capsule 3 times a day with food (a total of 801 mg/day) - from day 8 to 14 take 2 capsules, 3 times a day with food (a total of 1602 mg/day) - from day 15 onwards, take 3 capsules 3 times a day with food (a total of 2403 mg/day).

Swallow the capsules whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness. If symptoms continue, see your doctor.

Dose reduction due to side effects
Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.

If you take more Esbriet than you should
Contact your doctor, pharmacist or nearest hospital casualty department immediatelyif you have taken more capsules than you should, and take your medicine with you.

If you forget to take Esbriet
If you forget a dose take it as soon as you remember, but separate each dose by at least 3 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Esbriet
Do not stop taking Esbriet unless your doctor tells you to. If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with 1 capsule 3 times a day, gradually increasing this to 3 capsules 3 times a day.

If you have any questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Esbriet can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: - very common (affects more than 1 user in 10)
- common (affects 1 to 10 users in 100)
- uncommon (affects 1 to 10 users in 1000).

Stop taking Esbriet and tell your doctor immediately
- If you experience a serious allergic (hypersensitivity) reaction such as swelling of the face, lips and/or tongue, difficulty breathing or wheezing.
- If you experience a severe skin reaction to sunlight or sunlamps such as blistering and/or marked peeling of the skin. Severe photosensitivity reactions are uncommon. Avoid the sun (including sunlamps) whilst taking Esbriet, wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight to limit this reaction.

Other side effects may include
Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below.

Very common side effects affects more than 1 user in 10 skin reactions after going out in the sun or using sunlamps feeling sick nausea tiredness diarrhoea indigestion or stomach upset.

Common side effects affects 1 to 10 users in 100 infections of the throat or the airways going into the lungs andor sinusitis bladder infections weight loss loss of appetite difficulty sleeping

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Esbriet after the expiry date which is stated on the bottle label, blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store this medicine above 30ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Esbriet is a medicine that contains the active substance pirfenidone. It is available as blue and gold capsules (267 mg).

What is it used for?

Esbriet is used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which hard fibrous tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath. ‘Idiopathic’ means that the cause of the disease is unknown.

Because the number of patients with IPF is low, the disease is considered ‘rare’, and Esbriet was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 November 2004.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Esbriet should be started and supervised by a doctor experienced in the diagnosis and treatment of IPF. Patients receiving Esbriet should have their liver function checked before and regularly during treatment.

Esbriet is taken three times a day at mealtimes. The dose of Esbriet is increased steadily, starting with one capsule per meal in the first week, two capsules per meal in the second week and three capsules per meal from the third week onwards. The capsules should be swallowed whole with water.

Patients who experience side effects such as stomach problems, light-sensitive skin reactions or significant changes in the levels of liver enzymes may need to have their dose reduced at least temporarily..

How does it work?

The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood, but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of hard fibrous tissue during the body’s tissue repair process, thereby slowing down the progression of the disease in IPF patients.

How has it been studied?

The effects of Esbriet were first tested in experimental models before being studied in humans.

Esbriet was compared with placebo (a dummy treatment) in two main studies involving a total of 779 IPF patients. The first study also compared two different doses of Esbriet. In IPF patients, lung function worsens over time. In both studies, the main measure of effectiveness was therefore the change in the functioning of the patients’ lungs after 72 weeks of treatment, measured by their ‘forced vital capacity’ (FVC). FVC is the maximum amount of air the patient can breathe out forcefully after taking in a deep breath, which decreases as the condition gets worse.

What benefits has it shown during the studies?

In the first study, the patients taking Esbriet had a smaller reduction in FVC after 72 weeks than the patients taking placebo. The first study also found Esbriet to be most effective at the higher dose. The higher dose results from the first study, combined with the results of the second study (which involved the same higher dose), showed that the average reduction in FVC was 8.5% for patients taking Esbriet compared with 11% for patients taking placebo.

What is the risk associated?

The most commonly reported side effects during clinical study experience with Esbriet were nausea (feeling sick), rash, fatigue, diarrhoea, dyspepsia (heartburn), and photosensitivity reaction (skin reactions due to light sensitivity). For the full list of all side effects reported with Esbriet, see the package leaflet. Esbriet may also lead to raised levels of liver enzymes.

Esbriet should not be used in people who may be hypersensitive (allergic) to pirfenidone or any of the other ingredients. It must not be taken by patients already taking fluvoxamine (a medicine used to treat depression and obsessive compulsive disorder) or patients with severe liver or kidney problems.

Why has it been approved?

The CHMP noted that Esbriet had a modest effect on slowing down the progression of the disease, as measured by FVC, without serious risks for patients. It also noted the lack of effective alternative treatments. It therefore decided that Esbriet’s benefits are greater than its risks and recommended that it be given marketing authorisation.

How has it been studied?

The company that makes Esbriet will set up a post-authorisation safety study in order to collect additional information on patients prescribed Esbriet and suspected adverse reactions. The company must also ensure that all doctors who are expected to prescribe Esbriet are provided with an information pack containing safety information on liver function and light sensitive reactions.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Esbriet to InterMune Europe Ltd on 28 February 2011. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Esbriet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Esbriet can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.

This summary was last updated in 01-2011.

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Name

Esbriet 267 mg hard capsules

Composition

Each capsule contains 267 mg pirfenidone.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Hard capsule (capsule).

Two piece capsules with a blue opaque body and gold opaque cap imprinted with “InterMune 267 mg” in brown ink and containing a white to pale yellow powder.

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